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FDA 510(k)

EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z

K-Number: K011151 · 2001-05-15

ApplicantThe Olympus Optical Co.
Decision Date2001-05-15
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z is the device name listed in this FDA 510(k) record. The listed applicant is The Olympus Optical Co.. It received FDA 510(k) clearance on 2001-05-15 under 510(k) number K011151. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z?

EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z is a medical device that received FDA 510(k) clearance on 2001-05-15. The listed applicant is The Olympus Optical Co.. The 510(k) number is K011151.

When did EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z receive FDA 510(k) clearance?

EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z received FDA 510(k) clearance on 2001-05-15, under 510(k) number K011151.

Who is the listed applicant for EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z?

The FDA 510(k) record lists The Olympus Optical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z?

The FDA product code for EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z is FDS.

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Other records listing The Olympus Optical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032066SONOSURG SYSTEMK030194XUES-41 ENDOSCOPIC ELECTROSURGICAL UNITK021962OLYMPUS ULTRASONIC SURGICAL SYSTEMK023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESK023272DISPOSABLE ASPIRATION NEEDLE NA-200HK023767UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES

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Related Devices (Code: FDS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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